Manufacturing Engineer / Quality Specialist

Key Responsibilities

• Support manufacturing processes, including failure analysis, documentation review and approval, equipment qualification/calibration, and defect containments.
• Ensure manufacturing activities follow QMS.
• Support development and execution of process validation and verification test plans, protocols, and reports.
• Perform and coordinate PPAP inspections and product verification activities.
• Ensure compliance with drawings, specifications, and customer requirements.
• Administer and improve quality processes, with a focus on Lean process management.
• Aid manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation.
• Lead implementation and improvement of manufacturing-related quality processes.
• Continuous Improvement: Lead and manage initiatives in multiple product and process quality areas.
• Ensure successful, on-time completion of continuous improvement and capex projects.
• Support internal and external audits, prepare and review back-room documentation.
• Lead timely investigation (root cause analysis), disposition (including corrective and preventative actions), tracking, and reporting of non-conformances (NCP), both internal and supplier related.
• Track KPIs including delivery performance, NCPs, cost of quality, and customer satisfaction.
• Ensure QMS integrity during changes and process improvements.
• Maintain technical documentation in support of QMS.
• Maintain and improve the ISO 9001:2015 Quality Management System.
• Control and update the Quality Manual, procedures, and work instructions.
• Maintain and administer IQM (Ideagen Quality Management) system including document control, audits, assets, and workflow processes.
• Perform, Coordinate and Support internal and external (including customer) audits.
• Identify risks and opportunities and support QMS planning and improvements.
• Ensure controlled implementation of QMS changes and improvements in compliance with ISO standards.

Key Requirements

• Educational background: Associate’s degree in industrial engineering (IE), manufacturing engineering technology (MET), or equivalent (bachelor’s degree preferred).
• Skills: Pragmatic, entrepreneurial personality, and strong initiative-taker. Continually strives to improve.